Abstract

FORMULATION AND OPTIMIZATION OF ALOGLIPTIN ORALLY DISINTEGRATING TABLETS (ODTS) FOR IMPROVEMENT MANAGEMENT OF DIABETES

*Mrs. Kithir Fathima, Ms. S. Divyadharshini M.Pharm, Dr. V. Senthil M.Pharm. Ph.D., Dr. R. Arun M.Pharm. Ph.D.

Abstract

Aim: The aim of this study is to develop and optimise an orally disintegrating tablet (ODT) formulation of Alogliptin using a systematic approach, focusing on rapid disintegration, high mechanical strength, and efficient drug release to enhance patient compliance and therapeutic efficacy.Methods: A direct compression method was employed to formulate Alogliptin ODTs. The optimization was carried out using the Design of Experiment (DoE) approach, specifically employing Central Composite Design (CCD) for evaluating critical formulation factors such as compression force, disintegrant concentration (sodium starch glycolate), and lubricant concentration (magnesium stearate). Preformulation studies were performed to assess solubility, melting point, and drug-excipient compatibility. Post-compression parameters such as tablet hardness, disintegration time, friability, and dissolution were evaluated to ensure the quality of the tablets. Results: The formulation optimization revealed that compression force and disintegrant percentage significantly impacted the hardness and disintegration time of the tablets. The ANOVA results indicated that compression force had a major effect on both hardness and disintegration time (p < 0.05). Tablets showed satisfactory hardness (4.9–5.5 kg/cm²) and disintegration time (28–29 seconds), meeting the criteria for ODTs. Dissolution studies indicated that 90.14% of the drug was released within 15 minutes, with complete dissolution achieved by 45 minutes. The final optimised formulation successfully balanced rapid disintegration and mechanical strength, meeting the desired specifications.

Keywords: Alogliptin, orally disintegrating tablets (ODTs), Design of Experiment (DoE), compression force, sodium starch glycolate, magnesium stearate, dissolution, tablet optimization.